Urinary catheter provided as a package

ABSTRACT

A urinary catheter is provided as a package, where the package is an enclosed intermittent urinary catheter having a distal section and a proximal section. The distal section includes a urine exit port and the proximal section includes a urine entrance port and has a closed and rounded tip that is adapted to be inserted into a bladder.

FIELD OF THE INVENTION

The present invention relates to an elongated tubular catheter memberfor draining bodily fluids, e.g. from the bladder.

BACKGROUND OF THE INVENTION

Catheters for draining the bladder are increasingly used forintermittent as well as indwelling or permanent catheterisation.Typically catheters are used by patients suffering from urinaryincontinence or by disabled individuals like para- or tetraplegics whomay have no control permitting voluntary urination and for whomcatheterisation may be the way of urinating.

Catheterisation is thus increasingly becoming a daily-life proceduresignificantly improving quality of life for a large group of patients.

Typically, catheters are designed for one-time use and accordingly thecosts for producing, packing and sterilising a catheter is an importantissue. Existing catheters are made from a single piece of a continuouscatheter tube. Typically, the thickness of the catheter tube is constantthroughout its length.

The length of the catheter enables insertion of a certain length intothe urethra until urine starts to flow. At this point, a certainover-length of the catheter should be available. The over-lengthsupports for the user to firmly hold the catheter and to guide the urineto a place of disposal and to withdraw the catheter safely and withoutany risk of the catheter disappearing into the urethra.

Existing catheters are designed to minimise the risk of sores in themucous membrane and to give substantially no sensation of pain duringinsertion. Accordingly known catheters are typically provided with asmooth and slippery surface optimised for safe and comfortable insertioninto the urethra. Therefore, it may often be difficult, not least forthe disabled user, to handle the catheter by manipulation of theslippery over-length.

It is often important that the tubular member does not collapse or kinkand thereby blocks the passage for the urine to drain through thecatheter. Existing catheters are therefore typically made from a formstabile and relatively hard but still bendable tube e.g. made from PVC,PU or PE. Since the hardness of the tubes is selected relatively highwith the view to avoid kinking, the catheters may collapse if they arebend with a too small radius of curvature.

Accordingly, existing catheters not only have a considerable length butthey are also typically packed in an elongate condition. Therefore theexisting catheters may be troublesome to handle and to bring along, notleast for the individuals for whom catheterisation is a daily-lifeprocedure, wherein catheterisation takes place several times a day andwherein the used catheters must be disposed via the garbage collection.

DESCRIPTION OF THE INVENTION

It is an object of preferred embodiments of the present invention toovercome the above described disadvantages of the known catheters.

Accordingly, the invention provides a kit for preparing a catheter fordraining a human bladder, the kit comprising at least two cathetersections defining a longitudinally extending passage therein, thesections being arranged in a coextending fashion with a tubularprotective member surrounding a first, proximal one of said cathetersections, the kit further comprising a joint for interconnecting thefirst and the second catheter section, the joint defining asubstantially liquid tight seal at a distal end of a substantiallyannular and longitudinally extending cavity provided between theproximal end portion of the first catheter section and an inner wall ofthe tubular protective member, the tubular protective member beingremovably connected to the joint and/or to the second catheter section,so that, when the tubular protective member is removed, a proximal endportion of the first catheter section is exposed and ready for insertioninto the human urethra.

In particular, the catheter may be provided so that the sections areadapted to be moved between at least two positions with respect to eachother. One position being a position wherein the second sectionsurrounds the first section and the other position being a positionwherein the second section forms an extension for the first section.

The joint between the first section and the second section may be atelescopical joint providing a liquid tight seal between the sectionswhile they are moved between the first position and the second position.As an example, the first section may be provided with a piston sealadapted to slide along the inner surface of the second section while thefirst section is being pulled out of second section between the firstand second position.

In order to allow the user to insert the first section into a bodycanal, a locking arrangement of may be provided for locking the positionof the first section with respect to the second section, when thesections are in the second position, i.e. when the catheter is in aconfiguration ready for insertion into the body canal.

In order to allow the user to pull the first catheter section out of thesecond catheter section without touching the insertable part of thecatheter, the tubular protective member may preferably be provided toengage the first catheter section in a locking engagement. Thereby, itwill be allowed to use the tubular protective member to pull the firstcatheter section out of the second catheter section.

When the first catheter section has been pulled out of the firstcatheter section, i.e. when the sections are in the second position,i.e. in the position wherein the second catheter section forms anextension for the first catheter section, the tubular protective membershould be allowed to disengage the first catheter section. When thetubular protective member has been removed, the catheter is in a “readyto insert” state.

In order to use the second catheter section as a sealing envelope orpackage for the first catheter section, i.e. for the insertable cathetersection, the distal end of the first catheter section may preferably beadapted to seal an opening in a distal end of the second cathetersection while the sections are in the first position and not to seal setopening when the sections are in the second position. When the sectionsare brought into the second position, i.e. when the catheter is “readyfor insertion”, the opening in the distal end of the second section maybe used for draining the bodily liquids, e.g. urine out of the catheter.

In order to allow the annular cavity to be used e.g. for carrying africtional reducing substance, e.g. a water or saline solution for ahydrophilic catheter, a hydrogel or similar lubricating substance, thekit may preferably be provided with a sealing engagement between thetubular protective member and the first catheter section when thetubular protective member is engaging the first catheter section. Whenthe tubular protective member is disengaged from the first cathetersection, i.e. after the catheter has reached its “ready for insertionstate”, the annular cavity is open to the ambient atmosphere thusexposing the insertable tip of the first catheter section and allowingthe user to drain surplus friction reducing substances.

In one embodiment, the first catheter section is provided with ahydrophilic surface and the friction reducing substance provided in theannular cavity is a liquid swelling medium, e.g. water or a salinesolution.

The catheter sections could be provided in the form of oblong tubular,hollow sections wherein the passage is defined inside the sections orthe sections may comprise an oblong solid kernel with one or more vanesextending radially from the kernel and along the entire length thereof.The vanes thus defines a number of draining passages for draining urinebetween the kernel and a bodily draining passage, e.g. the urethra. Theadvantage of using a passage defined between a solid kernel and a wallof the urethra is that the flow of bodily fluid cleans the urethra andthus reduces the risk of infection compared with a traditional catheter,wherein the bodily fluid is drained inside the catheter isolated fromthe body canal.

A rigidity of substantially the full length of the catheter allows formanipulation of the catheter as one uniform catheter tube. Thereby,insertion of the proximal end of the catheter may be performed withouttouching the part of the catheter which is going to be inserted into theurethra. Preferably the catheter is provided with a bending momentdefined as the product between E-modulus and moment of inertia of atleast 1 MPamm⁴. Since the proximal (inserted) end of the catheter, formale individuals, must pass prostate in a curved passage, the proximalend portion of the catheter, e.g. the first 10-50 mm., such as 20-40mm., such as 25-35 mm, such as the first 30 mm. of the catheter may beprovided with an even lower bending moment defined as the productbetween E-modulus and moment of inertia of less than e.g. 0.6 MPamm⁴ oreven less than 0.3 MPamm⁴. Other parts of the catheter, e.g. a distalend portion where the urine is drained into the lavatory, a bag orsimilar place of disposal, may similarly be provided with a reducedbending moment.

The cross-sectional flow area or the hydraulic radius defined as theratio of the cross-sectional flow area to the wetted perimeter, may beselected independently upon the length, e.g. on the basis of the size ofthe urethra, which size depends on the individual using the catheter.Each of the sections may have either the same cross-sectional flow areaor hydraulic radius or each section may have individual cross-sectionalflow areas or hydraulic radiuses. However, at least one part of onesection should have a cross-sectional shape and size adapted for thesize of urethra or an artificial urinary canal. Similarly one sectionshould preferably have a length selected on the basis of the length ofthe urethra or the urinary canal. Thereby it may be achieved that onlyone section is to be inserted and therefore no transition betweensections needs to be inserted. However, especially for male individualswhere urethra is particularly long, a catheter having an inserted lengthdivided in two sections or more may be provided. In this specific caseit will be appropriate to provide a transition between the sectionswhich at least on the outer surface of the catheter have substantiallyno recess or sharp edge.

At least one of the catheter sections may be provided in a length in therange of 50-90 mm, such as in the range of 55-85 mm, such as in therange of 60-80 mm, such as with a length in the size of 70 mm, whichlength has been found to be a suitable insertable length for most femaleindividuals. For male individuals, catheter sections may be provided ina length in the range of 180-250 mm, such as in the range of 190-240 mm,such as in the range of 200-230 mm such as in the size of 220 mm. Forthe male individuals it may further be preferred to provide at least apart of the inserted end of the catheter in a material or in dimensionsso that a the tube becomes very flexible, without kinking. This willease the passage of the catheter past prostate.

The outer cross-sectional shape of at least one of the sections shouldpreferably be substantially circular with a cross-sectional area in therange of 0.5 mm²-30 mm².

Even more preferred is to provide at least one of the sections with ahydraulic radius (“cross-sectional area”/“circumferential length”) inthe size of 0.2-1.5 mm. Alternatively, at least one of the sectionsshould have a cross-sectional shape matching the shape of urethra or anartificial urinary canal, still with a cross-sectional area in the rangeof 0.5 mm²-30 mm² or a hydraulic radius in the size of 0.2-1.5 mm.However, the other of the sections does not necessarily have to have thesame cross-sectional shape, nor the same hydraulic radius. The wallthickness of the catheter should preferably be in the range between0.5-1.5 mm.

The catheter or at least a part of the catheter could be made from athermoplastic elastomeric material, other thermoplastic materials,curable elastomeric materials, polyamide resins or elastomers or anymixture thereof, i.e. the group may comprise materials like, PVC, PU,PE, latex, and/or Kraton'.

In one embodiment, the catheter may be divided in separate cathetersections. Each catheter section has at least one end provided with meansfor connecting the section with another section corresponding to anadjacent part of the catheter. As an example the catheter may be dividedinto two tubular connectable pieces connected by connecting means.

Preferably, the connecting means are provided with a rigidity allowingfor manipulation of at least one of the catheter sections bymanipulation of one of the other catheter sections. At least theconnection between each of the pieces should provide sufficient rigidityto allow one proximal section to be inserted into the urethra bymanipulation of one of the other sections.

Therefore, the connection is preferably provided so that at least thepart of the catheter extending the connection zone, has a bending momentdefined as the product between E-modulus and moment of inertia of atleast 0.6 MPamm⁴ such as at least 1 MPamm⁴. In order not to have theindividual sections falling apart during use, the connection shouldpreferably be adapted to take up an axial force of at least 0.5 Newtonor at least to take up an axial force larger than the axial forcerequired for withdrawal of the catheter from the urethra or artificialurinary canal.

The pieces may be connected e.g. telescopically or via a hinge enablingone of two sections to rotate in relation to the other of the twosections. It is appreciated that the sections are in fixed engagement sothat they do not disconnect during use of the catheter, while urine isdrained through the catheter. However, since the urine is always drainedin one direction, the connection does not necessarily have to beliquid-tight. As an example a telescopic connection may be establishedby inserting the section adapted for insertion into urethra into adistal section. The flow direction of the urine will at leastsubstantially prevent the connection from leaking even though theconnection as such is not completely liquid tight.

However, a completely sealed connection may provide an even safercatheter with a reduced risk of contaminating hands etc.

In one embodiment wherein the two catheter sections are arranged in atelescopic fashion, the first catheter section may be intended forinsertion into the human urethra, whereas the second catheter section isusually intended for forming a prolongation of the catheter outside thehuman urethra during use of the catheter. In use, that is in the secondmutual configuration of the two catheter sections, the second cathetersection preferably coextends with the first catheter section away from adistal end of the first catheter section. In the first mutualconfiguration, which usually is the configuration in which thetelescopic kit is stored and transported, at least a portion of thefirst catheter section may be surrounded by the second catheter section.In the first mutual configuration, the tubular protective member isprovided between an outer surface of the first catheter section and aninner wall of the second catheter section. The dimensions of the tubularprotective member and the catheter sections may be such that, in thesecond mutual configuration, a substantially annular and longitudinallyextending cavity is formed between an outer surface of the firstcatheter section and an inner wall of the second catheter section. Thefirst catheter section may have a hydrophilic surface, and a liquidswelling medium may be provided in the annular cavity, so as to swellthe hydrophilic surface of the first catheter section, whereby the firstcatheter section being encapsulated in the tightly sealed annular cavitymay be preserved in its wet, swelled condition for a period of 1-5years, such as 3-5 years, or more. A tight sealing of the annular cavityis desired for all kinds of catheter surfaces, including hydrophilic andhydrophobic catheter surfaces, in order to prevent contamination toenter into the cavity. Thus, in the first mutual condition, thetelescopical joint may serve to define a liquid and contamination tightseal between the second catheter section and an ambient atmosphere.

A distal end of the second catheter section is preferably provided witha tight seal which may be tight to both liquids and contamination, andwhich may be removable, so that when a distal end of the second cathetersection is inserted into, e.g., a urine collection bag, a passage forurine is formed at the location from which the seal has been removed.The tubular protective member is preferably removable when the first andsecond catheter sections are in the second mutual position, so that,when the tubular protective member is removed, the proximal end portionof the first catheter section is exposed and ready for insertion intothe human urethra. The distal end of the second catheter section may asan alternative be provided into one piece with a collection bag. As anexample, the second catheter section may be provided with a plasticwelding-flange for adhesively bonding a plastic collection bag to thesecond catheter section.

According to another preferred embodiment, the catheter may comprise atleast two sections not being separated but being divided by a bendablezone. The bendable zone could e.g. be a bellow shaped section or thezone could be an area wherein the thickness of the tubular material issmaller and wherein the zone accordingly has a lower bending moment. Thezone could e.g. be provided in a more resilient or flexible materialallowing for bending the catheter tube without kinking or damaging thetube.

In general, the problems of introducing a catheter into urethra dependnot only of the size of the introduced part of the catheter but also onthe slipperiness of the introduced part. The catheter section or atleast a part of the catheter section or sections adapted for insertioninto urethra or an artificial urinary canal may provide a surfaceslipperiness for easy and safe insertion. However, it has been foundthat lubricated or slippery surfaces, are difficult to handle, not leastfor a user having reduced dexterity. It is therefore an object of thepresent invention to provide a catheter with an inserted part beingtreated so as to provide a slippery surface and another part not beingtreated, so as to provide a surface which may easily be handled. Thedivision of the catheter into one part being treated and one part notbeing treated may preferably follow the aforementioned division of thecatheter with the purpose of making the catheter collapsible orseparable. According to an alternative embodiment, the parts may beprovided in the form of one part being smooth and another part beingprovided with a rough surface.

According to a preferred embodiment, at least one of the sections isprovided with gripping means easing a firm grip in the catheter. Notleast for the disabled user, the gripping means will improve the valueof the catheter considerably. Gripping means may be provided as aradially extending flange or flanges or as a zone having a large outercross sectional diameter. The catheter, or at least one of the cathetersections, may also be provided with means for engaging an externalhandle. As an example, one of the tubular catheter tubes may be providedwith a ring-shaped bulge for attaching a handle. The ring-shaped bulgecould be provided as a short tubular piece of plastic with a largerradial size than the catheter, the catheter being inserted and gluedinto the short piece of plastic.

A section provided with a hydrophilic surface treated with a liquidswelling medium may provide an excellent lubrication for the insertionand also provide compatibility with the body tissue. It is therefore afurther preferred embodiment of the invention to provide at least one ofthe sections with a hydrophilic surface layer.

One of the catheter sections could be used as a sterile package for theother sections, e.g. by arranging the sections in a telescopic mannerinside one section, closing and sealing that section in both ends, e.g.by a peelable and optionally a metallised foil e.g. made from athermoplastic elastomeric material, other thermoplastic materials,curable elastomeric materials, polyamide resins or elastomers or anymixture thereof, i.e. the group may comprise materials like, PVC, PU,PE, latex, and/or Kraton', thereby allowing for sterilising the assemblyby radiation.

The liquid swelling medium for the hydrophilic surface may be providedin the package for initiation of the low friction character already whenthe catheter is being packed. The liquid swelling medium may simply be asaline solution, a bactericidal solution capable of swelling thehydrophilic surface and capable of keeping the surface in a sterilecondition or it may be pure water. The swelling may also be initiatedalready before packaging of the catheter, the catheter then being packedin a substantially gas impermeable package for conservation of themoistened surface. Furthermore, the liquid swelling medium may beprovided in a capsule or container packed together with the catheter forswelling of the hydrophilic material immediately prior to the insertion.

According to another aspect the present invention relates to a bendableurinary catheter for draining a human bladder comprising:

-   -   a flexible elongated tube with an inner cross-sectional shape        and size defining a first conduit for draining urine, said tube        having an insertion end and a discharge end, and    -   a supporting member being introduced into the first conduit and        provided with an outer cross-sectional shape and radial size        substantially equal to the inner cross-sectional shape and size        of the elongate tube so as to support said tube against        collapsing during bending of the tube, the supporting member        having a flexibility allowing curling.

The discussion set forth above in connection with the features ofembodiments wherein the first and second catheter sections are arrangedin a telescopic fashion also apply to the kit aspects of the invention.Thus, embodiments of the kit may be regarded as modifications oftelescopic embodiments of the kit, the modification comprising that alongitudinal movement of the two catheter sections relative to eachother is usually not intended and that only one mutual configuration isusually intended. Further, all elements and features discussed above maybe provided in the kit, to the extent that such features and elementsare appropriate in the catheter.

With the catheter there may be provided a supporting member for beingintroduced into a first conduit of the catheter, the conduit being fordraining urine, the supporting member being provided with an outercross-sectional shape and radial size substantially equal to the innercross-sectional shape and size of the elongate tube so as to supportsaid tube against collapsing during bending of the tube, the supportingmember having a flexibility allowing curling.

The flexible elongated tube could have the shape of a regular catheterof the known kind. Preferably, the tube or at least a part of the tubeis made from a thermoplastic elastomeric material, other thermoplasticmaterials, curable elastomeric materials, polyamide resins or elastomersor any mixture thereof, i.e. the group may comprise materials like, PVC,PU, PE, latex, and/or Kraton™.

The supporting member supports the catheter to avoid collapsing when thecatheter is bend, e.g. for the purpose of packing the catheter in userfriendly short packages. The supporting member may be either solid orthe supporting member may be hollow and thus defining a second conduit.The solid supporting member should be adapted for removal prior todraining of the bladder, whereas a hollow supporting member may remaininside the tube while the bladder is emptied through the first andsecond conduit.

The supporting member may as an example be glued inside the elongatedtube or the supporting member may even be moulded into the tube duringthe process of producing the tube. The supporting member may even becompletely integrated in the elongated tube.

The supporting member could be made from any suitable material such ase.g. plastic, steel, aluminium, a thermoplastic elastomeric material,other thermoplastic materials, curable elastomeric materials, polyamideresins or elastomers or any mixture thereof. As an example, thesupporting member may be a helical spring provided in a length in therange of 20-60 mm, such as in the range of 30-50 mm, such as in therange of 35-45 mm. The spring should be positioned inside the elongatedtube in the zone where it is desired to bend the catheter, e.g. midwayalong the longitudinal axis of the elongated tube. During use, the urineis drained through the first conduit of the elongated tube and past thesupporting member through the second conduit.

In one embodiment, the supporting member is provided in a length in therange of 60-120 mm, such as in the range of 70-110 mm, such as in therange of 80-100 mm. and the supporting member may even be extending outof the discharge end of the elongated tube. This will enable the user toremove the supporting member during the process of inserting thecatheter into urethra.

The supporting member may be provided with gripping means for easingwithdrawal of the supporting member from the discharge end duringinsertion of the catheter.

A method for producing a urinary catheter comprising a proximalinsertion section defining an inner elongated passage for urine, and atleast one opening near a proximal end of the proximal insertion sectionfor allowing urine to pass from the human bladder into the innerelongated passage, may comprise the steps of:

-   -   providing a mould, defining the shape of at least the proximal        insertion section,    -   forming the proximal insertion section by injection moulding,    -   removing the proximal insertion section from the mould.

Whereas longitudinally extending catheters made from plastics materialshave hitherto been manufactured by a relatively costly process involvingextruding the catheter body, forming a rounded tip thereof by heattreatment, cutting transversely extending passages for urine near thetip of the catheter by means of a cutting tool, and rounding edges ofthe transversely extending passages by heat treatment, the methodaccording to the fourth aspect of the invention has the advantage thatit allows for a more efficient and more accurate controllablemanufacturing process with less waste of material and fewer productionsteps.

The catheter may further comprise a connector part for connecting theproximal insertion section to a further catheter section or to a urinarycollection bag. The connector part may be made from the same material asthe proximal insertion section, whereby, at the step of forming theproximal insertion section, the proximal insertion section and theconnector part may be formed substantially simultaneously.Alternatively, the connector part may be made from a material differentfrom the material of the proximal insertion section, whereby theconnector part and the proximal insertion section are formed in distinctprocess steps, for example in a multi-component injection mouldingprocess.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will now be described in detailswith reference to the drawing in which:

FIG. 1 shows an embodiment of the kit, wherein one catheter part isinserted for storage into another of the catheter parts thussubstituting a catheter package,

FIG. 2 shows the embodiment of FIG. 1, wherein the inserted catheterpart is partially withdrawn from one end of the package,

FIG. 3 shows the embodiment of FIGS. 1 and 2, wherein the insertedcatheter part is completely withdrawn from the package and then attachedto the other end of the package, the package thus functions as a handlefor manipulation of the catheter,

FIGS. 4-7 illustrate an embodiment of a kit according to the invention,wherein the catheter sections are arranged in a telescopic fashion,

FIGS. 8-11 show a further embodiment, wherein the catheter sections arearranged in a telescopic fashion,

FIGS. 12 and 13 show yet a further embodiment, wherein the cathetersections are arranged in a coextending fashion,

FIG. 14 shows a catheter kit according to the present invention,

FIG. 15 shows the catheter kit of FIG. 14, assembled into aconfiguration for use,

FIG. 16 shows a “Swiss-knife” embodiment of a catheter kit according tothe present invention,

FIG. 17 shows the catheter kit of FIG. 16, unfolded and arranged in aconfiguration for use,

FIG. 18 shows a collapsed catheter provided with a reinforcement sleeve,

FIG. 19 shows the catheter kit of FIG. 18, unfolded and in aconfiguration for use,

FIG. 20 shows a folded telescopic catheter kit,

FIG. 21 shows the catheter kit of FIG. 20, in an extended configuration,

FIG. 22 shows the catheter kit of FIG. 20, unfolded and after withdrawalof the combined closure and withdrawal cap,

FIG. 23, shows a preferred embodiment of a combined closure andwithdrawal cap for the kit shown in FIGS. 21 and 22,

FIG. 24 shows yet another preferred embodiment of a combined closure andwithdrawal cap for the kit shown in FIGS. 21 and 22,

FIG. 25 shows a kit wherein a distal part of the catheter is curled overinserted part of the catheter so as to protect the inserted part of thecatheter.

FIG. 26 shows a bendable catheter with a supporting member,

FIG. 27 shows a catheter part provided with gripping means for easingthe handling of the catheter,

FIG. 28 shows a preferred cross-sectional shape of a catheter partadapted for insertion into the urethra,

FIG. 29 shows a catheter produced by the method according to theinvention, and

FIGS. 30, 31, and 32 shows an embodiment of a catheter section whereinthe passage is defined between a solid kernel and the wall of a bodilychannel such as the urethra.

DETAILED DESCRIPTION OF THE DRAWINGS

Section I

FIG. 1 shows an embodiment of the catheter kit according to the presentinvention, wherein the first catheter section, not shown in FIG. 1, issterilely packed inside the second catheter section 21, the secondcatheter section being sealed in both ends with sealing caps or foils22,23.

Preferably the first section is coated with a hydrophilic coating,providing a low friction surface of the first catheter section whentreated with a liquid swelling medium. The coating could be of the kindwhich sustains being activated with the liquid swelling medium forlonger time, e.g. for several month. Thereby the liquid swelling mediumcould be provided in the catheter package from the time of packaging soas to provide a ready-to-use catheter. Hydrophilic coatings are knownper se, see e.g. the published patent applications WO 98/58988, WO98/58989, WO 98/58990 or EP 0570370. For this purpose, the sealing capsor foils should preferably be provided in a gas impermeable material forconservation of the humidity and thus the lubricity of the catheter forlonger time, e.g. for several month. As an example, the second cathetersection and/or the sealing caps may be made from a thermoplasticelastomeric material, other thermoplastic materials, curable elastomericmaterials, polyamide resins or elastomers or any mixture thereof, i.e.the group may comprise materials like, PVC, PU, PE, latex, and/orKraton'. The caps may be provided with a thickness allowing forsufficient gas impermeability. As an alternative, they may be made frommetallised foils.

As seen in FIG. 2, the first catheter section is easily withdrawn fromthe second catheter section by pulling the cap or foil 23 which cap orfoil engages the distal end of the first catheter section.

FIG. 3 shows the assembled catheter after the first catheter section hasbeen attached to the second catheter section. The foil or cap 23 caneither be removed completely as shown in FIG. 9 or can at least bepenetrated by the connecting means 24 of the second catheter section.

FIGS. 4-7 illustrate an embodiment of a catheter kit wherein the firstand second sections 42, 44 are telescopically interconnected. A tubularprotective member 46 surrounds a portion of the first catheter section42 and forms a substantially annular cavity 48 around the first cathetersection. In the second mutual configuration, shown in FIG. 16, in whichthe kit is intended to be stored and shipped, the first catheter section42 and the tubular protective member 46 are inserted as far as possibleinto the second catheter section 44. A hydrophilic swelling medium, suchas water, may be provided in the cavity 48, so that a hydrophilicsurface coating optionally provided at the surface of the first cathetersection 48 is stored in its swelled, i.e. wet condition. A surplus ofhydrophilic swelling medium may be present in the cavity 48 in order toprevent the hydrophilic surface coating from drying out. A liquid-tightseal 50 is provided at the distal end of the first catheter section 42.A liquid-tight closing member 52 closes the distal end of the secondcatheter section 44. In one embodiment, the closing member 52 isremovable so that a passage is provided between the second cathetersection 44 and a urine collection bag, or another device foraccumulating or conveying urine, mounted to the distal end of thesection catheter section 44, when the closing member 52 is removed. Inanother embodiment, the closing member 52 is an integrated part of thesecond catheter section 44, in which case a wall 53 of the closingmember 52 may be perforated in order to provide a passage between thesecond catheter section 44 and a urine collection bag, or other devicefor accumulating or conveying urine, mounted to the distal end of thesection catheter section 44. In yet another embodiment, the closingmember 52 may be substituted by a perforated end wall, e.g. a wall madefrom a central plate connected to the outer wall of the second cathetersection 44 at its distal end by means of radially extending ribs orspokes. In such an embodiment, the first catheter section 42 and theseal 50 may be formed as a single, integrated piece.

As shown in FIG. 5, an outer wall of the second catheter section 44forms a handle, the tubular protective member 46 being arranged so thatit extends out of the handle at the proximal end thereof. The tubularprotective member 46 may form a flange at its proximal end, so as tofacilitate a user's extraction of the first catheter section 42 and thetubular protective member 46 out of the handle/second catheter section44. When extracted, the tubular protective member 46 and thus the firstcatheter section 42 surrounded thereby coextend with the handle orsecond catheter section 44, as illustrated in FIG. 6. A protrusion 47 atthe distal end of the tubular protective member 46 releasably securesthe tubular protective member 46 to the seal 50, see FIGS. 4, 6 and 7.The seal 50 may be designed so that it engages the proximal end portionof the second catheter section 44 by a snap action once the seal 50 andthe tubular protective member 46 have reached the fully extractedposition shown in FIG. 6. In the example shown in FIG. 4, the seal 50has a groove 51 which, in the extracted position shown in FIGS. 6 and 7engages a flange 45 at the proximal end of the second catheter section44. Immediately prior to use of the catheter, the tubular protectivemember 46 is removed, so that the first catheter section 42 is exposed,as shown in FIG. 7.

FIGS. 8-11 illustrate a further embodiment of a catheter kit, whereinthe catheter sections are arranged in a telescopic fashion. As shown inthe exploded view in FIG. 11, the kit comprises the following parts: afirst catheter section 62, a second catheter section 64 with one or moreinner flange portions 65, a guide member 66 with protrusions 67, a joint69 with a collar portion 70 and slits 71 for the guide member 66, aswell as a distal closure member 72 and a proximal closure member 73. Thekit is stored and transported in the configuration shown in FIG. 8,wherein the second catheter section surrounds the first catheter section62 and the guide member 66. Prior to use of the catheter, the distalclosure member 72 is removed, and the guide member 66 is extracted, asshown in FIG. 9. The guide member 66 is extracted as far as possible,i.e. until the protrusions 67, due to their elasticity, engagerespective grooves (not shown) provided in the slits 71 of the joint 69,see FIG. 11. The joint 69 is secured from sliding out of the secondcatheter section 64 by means of the inner flange portions 65 of thesecond catheter section 64. The proximal closure member 73 is alsoremoved. Next, the guide member 66 is pushed back into the secondcatheter section 64. As the guide member engages the joint which isfirmly connected to the distal end of the first catheter section, thejoint 69 and the first catheter section 62 are pushed out of the distalend of the second catheter section 64 as the guide member 66 is pushedin the second catheter section 62. When the collar portion 70 of thejoint 69 engages an inner flange or protrusion provided at the proximalend of the second catheter section 64, the kit is ready for use, and thefirst catheter section 62 may be introduced into the urethra of a human.A urine collection bag or other means for accumulating or conveyingurine may be mounted to the proximal end of the second catheter section64.

The catheter shown in FIG. 12 has a first section 81 forming theproximal, insertable end of the catheter, and a second, proximal section82 forming a handle part of the catheter. The first and second sectionsmay have different shapes corresponding to their intended use. The firstsection is oblong and has an inlet opening 83 for draining urine fromthe bladder into an internal conduit extending through both part of thecatheter, and the first section is slim when compared to the secondpart. The first section is covered by a tubular protective member 84which is detachably attached to the outer surface of the catheter (inFIG. 1, the tubular protective member is removed and the catheter isready for insertion into the urinary tract). The disclosed tubularprotective member is cylindrical, and has an outward flange 85supporting removal of the sleeve from the catheter. An internal conduitconnects the inlet opening with the outlet opening 86 opposite the inletopening in the second part. The outlet opening is covered by a foil 87which is attached in a manner which allows peeling. A ribbed portion 88gives the user a tactile indication of the transition between the firstand the second section. The first and second sections are joined in ajoint 89, e.g. by gluing or welding. Alternatively, the sections may bemade in one piece.

FIG. 13 shows the catheter of FIG. 12, wherein the tubular protectivemember 84 is attached to the catheter. The second section 82 is notcovered by the tubular protective member. The tubular protective memberfastens to the second part via an inwardly extending flange (not shown)engaging the ribbed portion 88.

Section II

Referring to FIG. 14, a catheter kit according to the present inventioncomprises a first elongate tubular catheter section 1 adapted forinsertion into urethra or an artificial urinary canal and a secondelongate tubular catheter section 2 adapted for manipulation of thecatheter. At the proximal end 3, the tubular catheter section isprovided with holes 4 enabling urine to drain into the tubular member.In order to protect the mucous membrane, the holes may preferably beprovided on the side of the tubular member.

Alternatively, a tubular member may be provided with a hole in the tip.It is important that the edge of the hole is rounded smoothly or thatthe material, for at least this part of the tubular member, is selectedwith the view not to cut or damage urethra, i.e. e.g. a soft resilientrubber material.

At the distal end 5, the tubular member is provided with connectingmeans 6 for connecting the catheter section to mating connecting means 7of the second tubular catheter section. Preferably, the first and thesecond section is made from a thermoplastic elastomeric material, otherthermoplastic materials, curable elastomeric materials, polyamide resinsor elastomers or any mixture thereof, i.e. the group may comprisematerials like, PVC, PU, PE, latex, Kraton', PTFE (Teflon), FEP,Siloxane (silicone rubber), and/or FEP.

FIG. 15 shows a view of the assembled catheter. The second cathetersection is adapted to elongate the first catheter section so that thefirst and the second sections together form a rigid catheter havingsufficient length to enable catheterisation. The rigidity of the firstsection should be sufficient to allow the section to be inserted intourethra without collapsing the section. The second section and theconnection 6,7—as shown in FIG. 14—between the second section and firstsection is provided with a rigidity that allows the insertion of thefirst section by manipulation of the second section. As seen in FIGS. 14and 15, the catheter may preferably have gripping means 8 for easing afirm grip and manipulation of the catheter. In the embodiments of FIGS.14 and 15, the kit may preferably be packed in a sterile package.

As indicated in FIG. 15, the kit may comprise one handle section and anumber of catheter sections adapted for insertion or the kit mayalternatively be packed in two packages—one containing a handle formultiple use and another separately steriliseable package containing oneor more sections adapted for insertion and for one-time use. Thesections may as an example be packed in manner similar to cartridges ina revolver or in a cartridge belt, i.e. interconnected to form a longrow or tube of sections.

FIG. 16 shows a “Swiss-knife” embodiment of the catheter kit. The firstcatheter section 10 is folded into a slid 11 in the second cathetersection 12. The first catheter sections being rotatably hinged to thesecond catheter section in the hinge connection 13.

FIG. 17 shows the “Swiss-knife” embodiment unfolded. The slid 11 couldas an example be covered with a thin latex foil, so as to seal thesecond catheter section. When the catheter is folded, the first cathetersection will simply fold the latex foil radially inwardly into thesecond catheter section. As the catheter is unfolded, the elasticity anda slight pretension of the foil will lift the foil out of the slit andthereby provide free passage for urine to drain through the secondcatheter section. The latex foil is not shown in the FIGS. 16 and 17.

FIG. 18 shows an embodiment of the invention wherein a catheter issimply bend, whereby the catheter is divided into a first cathetersection 14 and a second catheter section 15 by a collapsed catheter part16. The catheter is provided with a reinforcement sleeve 17. Theconnector 18 enables connection of the catheter e.g. to a bag forcollecting the urine.

FIG. 19 shows the unfolded catheter of FIG. 18. The sleeve 17 has nowbeen displaced along the catheter so as now to support the catheteraround the collapsed part 16 of the catheter.

FIG. 20 shows an embodiment of the catheter kit wherein the first andthe second catheter sections are connected telescopically. The firstcatheter section is sterilely packed inside the second catheter section26. The second catheter section being sealed by a first sealing closure27 and a second sealing closure 28. Prior to use, the first sealingclosure is removed. If the first catheter section is provided with ahydrophilic surface layer, and if the catheter section is packed with aliquid swelling medium, the liquid medium may be emptied through thepassage opened by the first sealing closure. As best seen in FIG. 21,the second sealing closure engages the first catheter section 30 foreasy withdrawal of the first catheter section. When the first cathetersection has been completely withdrawn, the distal part of the firstcatheter section engages the proximal end of the second catheter sectionin the connecting zone 31 and the second sealing closure easilydisengages the first catheter section. The catheter is then in aconfiguration for use.

FIG. 23 shows a preferred embodiment of the second sealing closure 28,wherein the closure is provided with internal and radially inwardlyextending projections 33 adapted for engaging the hole 32 shown in FIG.22.

FIG. 24 shows another embodiment of the second sealing closure 28,wherein flexible gripping flanges 34 softly grips the proximal(inserted) end of the first catheter section for easy withdrawal of thefirst catheter section from the second catheter section upon removal ofthe second sealing closure.

The telescopic embodiment of the catheter kit, disclosed in FIGS. 20-24,should preferably be provided so that the internal diameter of thesecond catheter section is slightly larger than the external diameter ofthe first catheter section. This is an advantage, e.g. in the case wherethe first catheter section is coated with a hydrophilic surface coatingand in order not to scrape of the coating when sliding the firstcatheter section out of the second catheter section. On the other hand,it is an important aspect to provide a connecting zone wherein the firstcatheter section and the second catheter section firmly engages.Thereby, insertion and orientation of the first section is possiblemerely by manipulation of the second section and without the sectionsmutually sliding in the telescopic connection. It is furthermoreimportant to assure that the first catheter section does not slip out ofthe second section in which case the first catheter section mightdisappear into the urethra. For this purpose, the distal end (oppositethe inserted end) of the first catheter section may be provided with aradially outwardly extending flange disallowing the first cathetersection to slip out of the second catheter section.

FIG. 25 shows an embodiment of the catheter kit wherein a secondcatheter section surrounding a first proximal catheter section can beturned inside out thereby the second catheter section protects the firstcatheter section prior to use. By provision of sealing foils or caps inboth ends, the first catheter section may even be kept in a sterilecondition inside the second section. Before use, the second cathetersection is turned inside out by rolling or curling, whereby the catheteris brought into a configuration for use.

Referring to FIG. 26, one aspect of the present invention relates to abendable catheter. The catheter is provided e.g. as a soft and flexibleplastic hose 35, e.g. at least partly made from a thermoplasticelastomeric material, other thermoplastic materials, curable elastomericmaterials, polyamide resins or elastomers or any mixture thereof, i.e.the group may comprise materials like, PVC, PU, PE, latex, Kraton', PTFE(Teflon), FEP, Siloxane (silicone rubber), and/or FEP. The catheter isprovided with a zone 36 allowing the catheter to bend. The zone may asan example be formed as a below shaped part of the catheter. If thecatheter is relatively long and if a fairly large part of the catheteris to be inserted into the urethra, which is commonly the case for maleusers, it may be an advantage to provide a catheter which has a bendablezone which on the outside is so smooth that it may be inserted into theurethra. For this purpose the invention relates to a catheter having asupporting member inserted into at least the bendable zone. Thesupporting member may be a piece of an elongate helical spring providedwith a conduit for draining the urine. The spring will easily providesupport for the catheter so that the catheter does not collapse. Thespring should be provided with an outer diameter as close to the innerdiameter of the catheter hose as possible. As an example, the supportingmember may be provided as a small piece of a spring, glued inside thecatheter in the zone adapted to be bend. As another example, thesupporting member may be provided as a longer spring 37, extending outthrough the opening of the catheter in the distal end (opposite theinserted end) of the catheter. The supporting member may thereby beremoved prior to the insertion of the catheter into the urethra or evensimultaneously with the insertion of the catheter into the urethra. Forthis purpose the supporting member may be provided with a handle 38.

FIG. 27 shows a handle 40 for easy manipulation of the catheter. Thehandle may be highly appreciated not least for disabled users of thecatheter e.g. for people having a reduced dexterity.

FIG. 28 shows a preferred cross-sectional shape of the insertable partof the catheter. As the inserted part has an oval cross-sectional shape,the bending moment around the x-axis (indicated in FIG. 28) will bedifferent from the bending moment around the y-axis. The relatively lowbending moment around the y-axis will enhance the ability of thecatheter to bend in one direction, and thereby easy the insertion of thecatheter past prostate. The relatively high bending moment around thex-axis will enhance the general stiffness of the catheter thereby easingmanipulation of the inserted part of the catheter from the part of thecatheter not being inserted.

FIG. 29 illustrates a catheter produced by the method according to theinvention, the catheter having a proximal catheter section 60, at leastpart of which is adapted for insertion into the human urethra. Thecatheter section 60 forms one or more transversal passages 62, throughwhich urine may flow once a proximal end of the catheter section 60 isinserted into the bladder. The section 60 is further provided with arounded proximal tip 64 ensuring that the section can be insertedwithout damaging the membrane of the urethra. The catheter section 60 isformed in one single piece by injection moulding. The connector part 66is formed integrally with the catheter section 60 during the samemoulding operation. The connector part 66 may be adapted for connectionof the section to a handle section or to a urine bag.

FIG. 30 shows a perspective view of an embodiment of the catheter or acatheter section, comprising a solid kernel 281 with one or more vanes282 extending radially from the kernel and along the entire lengththereof. The vanes thus defines a number of draining passages 283 fordraining urine between the kernel and a bodily draining passage, e.g.the urethra. The advantage of using a passage defined between a solidkernel and a wall of the urethra is, that the flow of bodily fluidcleans the urethra and thus reduces the risk of infection.

FIG. 31 shows a side view of the catheter section shown in FIG. 30. FIG.32 shows a top view of the catheter shown in FIGS. 30 and 31. FIG. 32shows the solid part 281 connected to a number of vanes 282.

The vanes are again connected to a connector 302 via a number of spokes301. A number of openings 303 are formed between the solid catheter part281 and the connector 302. Except from the fact that the passage isdefined between a solid core and the wall of the bodily channel and notinside a hollow tubular body, the catheter section of FIGS. 30-32corresponds to the catheter section 42 of FIG. 4. The openings 303correspond to the perforations of the catheter section of FIG. 4. Theopenings are provided in order to allow a friction reducing substance todrain out of the cavity 48 defined between the first and second cathetersection, c.f. FIG. 4. The spokes 301 may preferably be formed with dueregard to fluid dynamic aspects in order to allow fluid to drain passedthe spokes without causing turbulence and without spreading the fluid.Spokes with a cross-sectional shape of a rhombus arranged with thelongest leg parallel to the flow-direction, will support a substantiallyundisturbed flow passed the spokes.

What is claimed is:
 1. A catheter assembly comprising: a packageextending from a distal end to a proximal end that forms a flange, withthe package having an interior surface that forms a cavity; anintermittent urinary catheter disposed in the package and including aproximal end that is adapted for insertion into a bladder of a user; aseal coupled to a distal end of the intermittent urinary catheter; ahydrophilic coating applied to the intermittent urinary catheter; and aliquid disposed in the cavity and in contact with the hydrophiliccoating applied to the intermittent urinary catheter; wherein the sealis configured to slidingly couple with the interior surface of thepackage as the proximal end of the intermittent urinary cathetertelescopes out of the package prior to the seal engaging with the flangeat the proximal end of the package.
 2. The catheter assembly of claim 1,wherein the seal includes a groove that is adapted to engage with theflange at the proximal end of the package.
 3. The catheter assembly ofclaim 1, further comprising a tube placed inside of the package andaround the intermittent urinary catheter, with the tube coupled to theintermittent urinary catheter.
 4. The catheter assembly of claim 1,further comprising: a tube placed inside of the package and coupled tothe seal of the intermittent urinary catheter; wherein the tube isadapted to pull the intermittent urinary catheter out of the package. 5.The catheter assembly of claim 1, wherein the distal end of the packageprovides an opening that is adapted to allow urine to pass from thebladder, through the intermittent urinary catheter and the package, andout of the opening.
 6. The catheter assembly of claim 1, wherein thepackage is a closed package including a tube placed inside of thepackage to close the proximal end of the package and a removable closureattached to the distal end of the package.
 7. A catheter assemblycomprising: a closed package including a tube placed inside of thepackage to close a proximal end of the package and a closure attached toa distal end of the package; an intermittent urinary catheter containedin the closed package, with the intermittent urinary catheter includinga proximal end that is located inside of the tube; a seal coupled to adistal end of the intermittent urinary catheter, where the seal isadapted to engage the closure to provide a liquid-tight coupling at thedistal end of the package; a hydrophilic coating applied to theintermittent urinary catheter; and a liquid contained in the closedpackage and contacting the hydrophilic coating applied to theintermittent urinary catheter; wherein the tube is coupled to the sealsuch that removal of the tube out the package causes the proximal end ofthe intermittent urinary catheter to telescope out of the package.
 8. Amethod of draining urine from a bladder of a user, the methodcomprising: providing a hydrophilic coated intermittent urinary catheterand a liquid contained inside of a closed package; removing a tube outof a proximal end of the closed package and A) opening the package toprovide an opened package; B) telescoping a proximal end of thehydrophilic coated intermittent urinary catheter out from the proximalend of the opened package; and C) draining the liquid out of a distalend of the opened package; and using the hydrophilic coated intermittenturinary catheter that has been telescoped out from the proximal end ofthe opened package to drain urine from the bladder of the user, throughthe hydrophilic coated intermittent urinary catheter, and out of thedistal end of the opened package.
 9. The method of claim 8, furthercomprising pulling the tube out of a proximal end of the closed packageand discarding the tube.